MAUDE Adverse Event Report: ST. JUDE MEDICAL SYSTEMS AB PRESSUREWIRE AERIS; GUDIEWIRE SENSOR

Model Number C12058

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2014

Event Type  malfunction  

Event Description

The pressurewire was trapped in a small septal branch.The pressurewire was removed from the patient without problem.Another pressurewire was used without any problem.

Manufacturer Narrative

No evidence of externally induced markings (like scratching), inherent weak spots (like inclusions) or flaws from the manufacturing process that could have contributed to the failure were found on the core wire.From the visual examination and analysis of sem images it is likely that the fracture was caused by mainly rotational force and then last section of the fracture occurred due to tensile and rotational force.A review of the device history record confirmed that the device was manufactured according to (b)(4) specification.

• Brand Name: PRESSUREWIRE AERIS
• Type of Device: GUDIEWIRE SENSOR
• Manufacturer (Section D): ST. JUDE MEDICAL SYSTEMS AB; palmbladsgatan 10; box-6350; uppsala SE-75 135; SW SE-75135
• Manufacturer Contact: emil anderas ; palmbladsgatan 10; box 6350; uppsala SE-75-1 35 ; SW SE-751 35 ; 8161000
• MDR Report Key: 4134655
• MDR Text Key: 4946304
• Report Number: 8030904-2014-00013
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K113584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2016
• Device Model Number: C12058
• Device Lot Number: 4596615
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 101